Experience

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  Allergan

  Jan 1995 - Jan 1997

  • Manufacturing Engineer

    Jan 1995 - Jan 1997

  • Manufacturing Engineer

    Jan 1995 - Jan 1997
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  Pharmabio serv

  Jan 1997 - Jan 1998

  Validation specialist
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  Abbott laboratories

  Jan 2000 - Jan 2001

  Production engineer
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  Weil group, inc.

  Sept 2003 - Feb 2006

  Validation specialist

  Caguas, PR•Performed full validation activities: including protocols preparation and Final Report submissions. Audited validation packages (cleaning validations, equipment qualifications, process validations and utilities qualifications) to ensure compliance with GMP’s and Regulatory agencies. Worked in different projects as Weil Group Specialist that are summarized as follows:•Ortho-McNeil Pharmaceuticals, Inc. Manatí PR (September 2005 - February 2006)Preparation of Installation and Performance Qualification Protocols for new optic technology equipment on a production line.•Bristol-Myers Squibb CompanyBarceloneta, PR (September 2003-June 2004, October 2004-April 2005)Evaluation of validation and qualification documentation for all the cleaning processes, manufacturing processes, production equipments, production rooms, utilities, HVACs and computer systems associated with manufacturing to ensure compliance with GMP’s and BMS Guidelines.Verification of the calibration and identification of all the production and utilities instrumentations as identified in the field against calibration records.Verification of the actual water systems against the validation packages and engineering drawings.Evaluation of all HVAC’s systems to ensure compliance with GMP’s and BMS Guidelines.Developed systems to ensure the compliance to the BMS GMP Work Plan.•Eli Lilly del CaribeCarolina, PR (July 2004-September 2004)Performed Installation Qualification of Production Equipment.Verification of actual installation of piping against the P&ID’s.Submitted IQ Reports. Show less

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  App pharmaceuticals

  Jan 2008 - Jan 2009

  Contiuous improvement engineer - technical writer investigator

  Investigated all the non-conformance products related to the parenteral manufacturing process in APP Pharmaceutical, including but not limited to production, manufacturing, aseptic filling, packaging, in-process and release Out-of-Specification testing results and environmental monitoring issues of the Manufacturing Department.Prepared investigation reports and risk analysis of non-conformance products including corrective and preventive actions coordination and meetings with the APP management to discuss the investigations.Performed Risk Assessment evaluation of the manufacturing Issues Show less

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  Abbott vascular

  Jan 2010 - Jan 2011

  Senior quality analyst

  Investigate complaints from distribution centers around the world related to product manufactured by Abbott Vascular PR. Determine global Corrective Actions to avoid reoccurrence of events related to distribution centers complaints.Investigate non conforming products, audit findings, out of action product rejection rates and other non-product related exceptions. Determine the corrective and preventive actions to avoid reoccurrence.Implement corrective and preventive actions including but not limited to: change procedures, design training modules and re-training of personnel.Evaluate transfer and validation documents to ensure regulatory compliance and determine remediation activities when applicable.Audit the Quality System to ensure compliance with Regulations and Company Policies.Review and approve investigations from the Quality Assurance Regulatory and Compliance perspective. Show less

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  Pfizer

  Nov 2011 - Sept 2013

  New product development.Establish the manufacturing strategy for product develoment trials with R&D group.Coordinate with Manufacturing, QA, QO laboratory, Distribution, Procurement, Import/Export Logistic, Finance, Clinical Supply and Global Supply Chain the major activities to support manufacturing, raw material approval, product approval and supply of the product under development.Aid in the development of a new product as a technical liaison between R&D, Global Technical Services and Manufacturing.Lead raw materials qualification, technology transfer and new equipment qualification to support the new product development. Coordinate the phase 3 clinical batches manufacturing, including, but not limited to: issuance of Manufacturing Instructions, Study Reports and raw material specifications. Show less Lead the implementation of assigned product change projects.Lead new presentation launches to meet Market requests.Liaison with Regulatory, Market, Customer Service, Global Supply Chain, Technical Engineering Services, Laboratory and Quality Assurance being a point of contact during projects implementation.Negotiate with Planner, Supply Chain Management-NY and Market the implementation of new product presentations or changes in established products.Provide leadership to the changes evaluation in Raw Materials and Drug Products. Show less

  • Process Engineer (Contractor)

    Dec 2012 - Sept 2013

  • Project Management Specialist (Contractor)

    Nov 2011 - Dec 2012
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  Biothermal llc

  Sept 2013 - Sept 2017

  Establish the Validation Strategy for the New Automated Visual Inspection Lines.Manage senior and junior level validation specialists during qualification and engineering studies development.Write, review, and execute IQ, OQ and PQ protocols and engineering studies.Develop recipes for the High Voltage Leak Detection Machine – Nikka Densok.Assist in the recipe development for the Bosch (Eisai) Automated Visual Inspection Machine. Qualification of Automated Inspection Machines Recipes.Support the identification of critical process parameters and acceptance criteria for development and validation of Automated Inspection Process.Provides technical support to all Visual Inspection related subjects for Hospira.Support in Adjustment / tuning automated inspection machines.

  • Site Validation Manager

    Dec 2014 - Sept 2017

  • Validation Engineer

    Sept 2013 - Sept 2017
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  Covectra, inc.

  Jul 2017 - Dec 2018

  Qa manager

  Testing and configuration of Serialization Systems. Start up of serialized packaging lines.

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  Propharma group

  Nov 2018 - Jan 2020

  Project manager

  Responsible for FAT, SAT, engineering studies, IQs, OQs, PQs of a new Automated Visual Inspection Line.Write VPP and establish the validation strategy for Lyo product Automated Visual Inspection Line.Write and execute all commissioning, qualification and engineering study protocols for the Lyo AVI line.Support SAT execution for new serialization line.

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  Bristol myers squibb

  Jan 2020 - Aug 2020

  Packaging validation engineer

  Qualification of Serialization Lines

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  Biothermal llc

  Oct 2020 - Mar 2022

  Senior validation engineer
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  Self-employed

  Mar 2022 - now

  Lawyer